Quigley Files IND Application to FDA for Diabetic Neuropathy Drug
The Quigley Corporation has filed an application with the FDA to begin clinical trials of QR-333 for the treatment of diabetic peripheral neuropathy.
If the FDA approves, studies with human subjects will commence as soon as possible.
Included within the Investigational New Drug (IND) application are protocols for studies including a Phase IIb human study designed to evaluate the efficacious dose range of the compound and a Phase II pharmacokinetic study evaluating safety.
“The filing of this IND is a milestone in the drug development process as well as for Quigley Pharma,” stated Dr Richard Rosenbloom, COO of Quigley Pharma.
Filed under Diabetes
